Rozerem Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,339
- 主要终点
- Number of Participants Reporting One or More Adverse Drug Reactions
研究概览
简要总结
The purpose of this study is to investigate the safety and efficacy of ramelteon (Rozerem) when used in the routine clinical setting in patients with sleep-onset difficulty associated with insomnia.
详细描述
This is a drug use surveillance planned to examine the safety and efficacy of ramelteon tablets when used in the routine clinical setting in patients with sleep-onset difficulty associated with insomnia (planned sample size, 3000)
The usual adult dosage is 8 mg of ramelteon administered orally once daily at bedtime.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sleep-onset difficulty associated with insomnia
排除标准
- •Patients with previous history of hypersensitivity to an ingredient of Rozerem Tablets
- •Patients with severe liver dysfunction
- •Patients taking fluvoxamine maleate
研究组 & 干预措施
Ramelteon 8 mg administered orally once daily
干预措施: Ramelteon (Drug)
结局指标
主要结局
Number of Participants Reporting One or More Adverse Drug Reactions
时间窗: Baseline up to 6 weeks
Adverse drug reactions are defined as adverse events (AE) which are in the investigator's opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
Number of Participants Reporting One or More Serious Adverse Drug Reactions
时间窗: Baseline up to 6 weeks
Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
次要结局
- Sleep Status: Total Sleep Time(Baseline and Week 4)
- Percentage of Participants Who Responded With Improvement on the Patient Global Impression (PGI) Scale at Week 4(Week 4)
- Sleep Status: Number of Awakenings(Baseline and Week 4)
- Sleep Status: Sleep Onset Latency(Baseline and Week 4)